Samenvattingen, Aantekeningen en Examens
Op zoek naar een samenvatting over ? Op deze pagina vind je 501 samenvattingen over .
Alle 501 resultaten
Sorteer op
-
SOCRA EXAM PREP | 2023/ 2024 Newly Updated | ALL EXAMS COMBINED| Questions and Verified Answers| Highly Rated Guide
- Tentamen (uitwerkingen) • 356 pagina's • 2023
-
- $13.99
- 2x verkocht
- + meer info
SOCRA EXAM PREP | 2023 Update | Questions and Verified Answers| Highly Rated Guide 
 
Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? 
 
Answer: 
1) Progress of investigations under IND 
2) Secure compliance or discontinue investigators that are not compliant and notify FDA 
3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 
4) Notify FDA, all IRBs and all investigators if drug presen...
-
SOCRA Bundled Exams Questions and Answers Latest Update (2023/2024) (Complete and Accurate)
- Voordeelbundel • 10 items • 2024
-
- $20.49
- 2x verkocht
- + meer info
SOCRA Bundled Exams Questions and Answers Latest Update (2023/2024) (Complete and Accurate)
-
SOCRA UPDATED Exam Questions and CORRECT Answers
- Tentamen (uitwerkingen) • 13 pagina's • 2024
-
- $8.49
- + meer info
Which of the following is a disclosure of financial interests form? - FDA Form 3455 
Which of the following is a certification of financial interest form? - FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit the 
following form: - FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - 
Investigational New Drug Application (1571) 
In the top right corner, form have OMB number. What does it stand ...
-
SOCRA TOP Exam Guide Questions and CORRECT Answers
- Tentamen (uitwerkingen) • 25 pagina's • 2024
-
- $8.99
- + meer info
When isn't an IND application needed? - IND Application is not needed if investigation 
does not support change in labeling. 
What information must the general IND include? 
(21 CFR Part 312.23) - -FDA Form 1571 
-FDA Form 1571 cover sheet 
-Table of contents 
-Investigative Plan 
-Investigator's brochure 
-Protocol 
-Chemistry/Manufacturing information 
-Pharmacology/Toxicology 
-Previous human research/literature information 
-Additional information (drug dependence and abuse potential)
-
SOCRA PASSED Exam Questions and CORRECT Answers
- Tentamen (uitwerkingen) • 16 pagina's • 2024
-
- $8.99
- + meer info
Respect for persons, justice, beneficence - List the three ethical principles of the 
Belmont report 
Experiment that involves a test article and one or more human subjects - does not include 
experiments which are nonclinical lab studies - Define clinical investigation 
Someone who is or becomes A participate in research either as a recipient of the test article or 
as a control - Human subject is: 
Life threatening circumstances deem use of test article necessary, inability to communicate o...
-
SOCRA EXAMS BUNDLE| Questions with 100% Correct Answers
- Voordeelbundel • 6 items • 2024
-
- $26.31
- + meer info
SOCRA EXAMS BUNDLE| Questions with 100% Correct Answers
-
SOCRA (CCRP) Exam Practice Questions and Answers 2024
- Tentamen (uitwerkingen) • 2 pagina's • 2024
-
- $7.99
- + meer info
The Belmont Report's principle of respect for persons incorporates at least two ethical 
convictions: first, that individuals should be treated as autonomous agents, and second, 
that: - CORRECT AND ANSWER-Persons with diminished autonomy are entitled to 
protection. 
Which of the following is an example of how the principle of beneficence can be applied 
to a study employing human subjects? - CORRECT AND ANSWER-Determining that 
the study has a maximization of benefits and a minimization ...
-
SOCRA Practice Test Certification Final Exam Questions with 100% Correct answers
- Tentamen (uitwerkingen) • 10 pagina's • 2024
-
- $7.99
- + meer info
Which of the following is a disclosure of financial interests form? - CORRECT 
ANSWER-FDA Form 3455 
Which of the following is a certification of financial interest form? - CORRECT 
ANSWER-FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit 
the following form: - CORRECT ANSWER-FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - 
CORRECT ANSWER-Investigational New Drug Application (1571) 
In...
-
Socra Exam Prep Test 2024- with 100% Correct Answers ( A Graded)
- Tentamen (uitwerkingen) • 25 pagina's • 2024
- Ook in voordeelbundel
-
- $13.49
- + meer info
Laws - ANSWER passed by national legislative bodies; establish authority of national regulatory 
body 
Regulations - ANSWER Passed by regulatory authorities; controls how medical products are 
investigated and approved; have effect of law 
guidance - ANSWER "current thinking" of regulatory bodies; non-binding 
ICH - ANSWER Developed to keep people doing things the same way across the world; 
international effort to harmonize the technical requirements for product registration
-
SOCRA EXAM 2024- with 100% Correct Answers ( A Graded)
- Tentamen (uitwerkingen) • 50 pagina's • 2024
- Ook in voordeelbundel
-
- $13.49
- + meer info
SOCRA EXAM 2024- with 100% Correct Answers ( A 
Graded) 
Electronic signature are currently accepted for any and all records, paper or electronic form. 
True or False? - ANSWER False. The general provisions for electeonic signature criteria apply to 
records that are 
i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form 
ii. The criteria do not apply to paper records that are or have been transmitted by electronic 
means. 
If the electronic records meet the c...
-
SOCRA Practice Test - with 100% Correct Answers ( A Guaranteed)
- Tentamen (uitwerkingen) • 14 pagina's • 2024
- Ook in voordeelbundel
-
- $12.89
- + meer info
Which of the following is a disclosure of financial interests form? - ANSWER FDA Form 3455 
Which of the following is a certification of financial interest form? - ANSWER FDA Form 3454 
If the investigator did have financial arrangement with the sponsor, he/she would submit the 
following form: - ANSWER FDA Form 3455 
This form is submitted by sponsor to the FDA prior to the beginning of the drug trial - ANSWER 
Investigational New Drug Application (1571)
-
Socra CCRP Exam Prep Test 2024- with 100% Correct Answers ( A Graded)
- Tentamen (uitwerkingen) • 6 pagina's • 2024
- Ook in voordeelbundel
-
- $12.24
- + meer info
Contract Research Organization - ANSWER A person or an organization (commercial, academic, 
or other) contracted by the sponsor to 
perform one or more of a sponsor's trial-related duties and functions. 
When a short form is used for informed consent the witness must sign the short form or the 
summary? - ANSWER False-they must sign both 
What is FDA form 3454 - ANSWER Certification Financial Interests and Arrangements of Clinical 
Investigators